Spiration Valve System recall: Labeling Error
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and…
Why was Spiration Valve System recalled?
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
- Product
- Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 35 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)